Blood Banks Licences

Blood Banks Licences

•    The licence for operating a blood bank shall be issued in form 28 C.
•    A blood blank shall have an area of 100 square metres for its operations and an additional area of 50 square metres for preparation of blood components.


Documents required for grant/renewal of blood bank licences

1 Covering letter with court fee stamp with  5 rupees affixed.
2 Form 27.C( Refer Statutory forms)
3 Questionnaire.
4 Chalan for Rs. 7500/- remitted under the head of account 0210-04-104-99.
5 Plan  of the building.
6 Declaration of the medical officers, technicians and technical supervisor (blood component units) and registered nurses.
7 Attested copies of qualification of the medical officers, technicians and technical supervisors
8 Experience certificates of medical officers,technicians and technical supervisors
9 List of equipments provided.
10 List of blood products required.
11 Details of labels.
12 Standard operating procedures.



The validity of Drug Licence is 5 years from the date of grant of drug licence.


The operation of Blood bank and/or processing of whole human blood for components shall be conducted under the active direction and personal supervision of whole-time  competent technical staff consisting of :

(i) Medical Officer,  possessing-

a. Postgraduate degree in Medicine-M.D. (Pathology/Transfusion Medicines) or
b.
Degree in Medicine (M.B.B.S.) with Diploma in Pathology or Transfusion Medicines having  adequate knowledge in blood group serology, blood group methodology and medical principles involved in the procurement of blood and/or preparation of its components; or
c. Degree in Medicine (M.B.B.S.) having experience in Blood Bank for one year during regular service and also have adequate knowledge and experience in blood group serology, blood group methodology and medical principles involved in the procurement of blood and/or preparation of its components.The degree or diploma being from a University recognized by the Central Government.


(ii)     Blood Bank Technician (s), possessing-

a.
Degree in Medical Laboratory  Technology(M. L. T) with six months experience in the testing of blood and/or its components; or
b. Diploma in Medical  Laboratory  Technology (M. L. T) with one year experience in the testing of blood and/or its components


The degree or diploma being from a University /Institution recognized by the Central Governmentor State Government.


(iii)    Registered Nurse(s)

(iv)   Technical Supervisor (where blood components are manufactured),possessing –

a.
Degree in  Medical  Laboratory  Technology (M. L. T) wit six month`s experience in the preparation of blood components ; or
b.
Diploma in Medical  Laboratory  Technology (M. L. T) with one year experience in the
preparation of blood components,


The degree or diploma being from a University /Institution recognized by the Central Government
or State Government.

Permit for Blood Storage Centres

The validity of permit is 2 years from the date of grant of permit

Documents required for the approval of blood storage centres

1 Covering letter with court fee stamp with Rs. 5 affixed.
2 Prescribed application form  (see below)
3 List of equipments provided.
4 Declaration of the medical officer and laboratory technician.
5 Attested copy of qualification and experience certificate of medical officer and technician.
6 Consent of the mother blood bank supplying the blood units.
7 Plan of the proposed building.